| Parameter | Value |
|---|---|
| Unique Study ID | AA-AA-000-0000 |
| Protocol title | Protocol Title |
| Protocol nickname | Protocol Nickname |
| Sites (Enrolled / Planned) | 176 / 190 |
| Participants (Enrolled / Planned) | 1301 / 1300 |
| Parameter | Value |
|---|---|
| Unique Study ID | AA-AA-000-0000 |
| Protocol title | Protocol Title |
| Protocol nickname | Protocol Nickname |
| Sites (Enrolled / Planned) | 176 / 190 |
| Participants (Enrolled / Planned) | 1301 / 1300 |
| Date that snapshot was created | 2023-11-02 |
| Risk-based monitoring flag | Y |
| Study Status | Active |
| Product | Product |
| Phase | P3 |
| Therapeutic Area | Therapeutic Area |
| Indication | Protocol Indication |
| Protocol type | Investigator Sponsored |
| Protocol row ID | 1-1G9113 |
| Protocol product number | 123 |
| # of enrolled sites from GILDA | 176 |
| # of enrolled participants from GILDA | 1301 |
| First-patient first visit date | 2003-01-01 |
| Estimated first-patient first visit date from GILDA | 2003-01-01 |
| Last-patient first visit date | 2020-06-01 |
| Estimated last-patient first visit date from GILDA | 2020-06-01 |
| Last-patient last visit date | 2021-06-01 |
| Estimated last-patient last visit date from GILDA | 2021-06-01 |
| Average snapshot interval | 578.6 days |
| Median snapshot interval | 365 days |
24 Red KRIs
65 Amber KRIs
As of 2023-11-02, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 24 Site-KRI combinations have been flagged as red across 16 sites as shown in the Study Overview Table above
16 sites have at least one red KRI
60 sites have at least one red or amber KRI
116 sites have neither red nor amber KRIs and are not shown
No Inactive KRI’s